ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER— 510(k) K002627

Name: FDA 510(k) clearance K002627
Creator: U.S. Food and Drug Administration
Published: 2001-04-26

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K002627 for ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER, Substantially Equivalent on 2001-04-26. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2000-08-23
Decision date: 2001-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.